1. Field of the Invention
The systems and methods of this invention relate to electrical stimulation treatments to enhance bone growth and fusion of bones using implantable devices. Specifically, the present invention relates to systems and methods for providing such stimulation without the use of conventional lead/electrode systems.
2. Description of the Background Art
Electrical stimulation of body tissues is used throughout medicine for treatment of both chronic and acute conditions. One such therapeutic application is using electrical stimulation to increase the rate of bone regrowth, repair, fusion of bones or bone grafts. Commonly implanted devices utilizing electrical stimulation for treatment in bone fusion are made by such companies as Biomet (Electro-Biology, Inc. (EBI)). Similarly, ultrasound energy has been used as a noninvasive therapeutic healing application in bone treatments, such as in the Exogen Bone Healing System made by Smith&Nephew.
Electrical bone growth stimulation (EBGS) generally refers to the treatment of bone fusion or repair using electrical current (direct current or alternating current). Currently, invasive use of these devices involves surgical implantation of a current generator in an intramuscular or subcutaneous space, while an electrode is implanted within the fragments of bone or bone graft at the bone fusion site. Limited by battery utilization, the implantable device typically remains functional for six to nine months after implantation; alternatively, it can be adapted to be rechargeable. Although the current generator is removed in a second surgical procedure when stimulation is completed, the electrode may or may not be removed. Noninvasive approaches that apply an electrical or electro-magnetic field transcutaneously to the bone area via externally worn devices are also available. Ultrasonic bone growth stimulation (UBGS) generally refers to the treatment of bone fusion and repair using low-intensity ultrasound as an energy source and the ultrasound energy is externally applied. In noninvasive electrical applications, electrical devices require patient interaction to apply and remove electrodes. Compliance with noninvasive EBGS and UBGS is often an issue because it requires the patient to apply the therapy at a prescribed regimen and intensity. Patients may not keep batteries charged, may not comply with instructions, may fail to wear electrodes for required durations, or may adjust intensities inappropriately for the electrical bone stimulation therapy or ultrasound therapy application to be effective.
EBGS is used as an adjunct to spinal fusion surgery, with or without associated devices such as cages or screws to enhance the chances of obtaining a solid spinal fusion. EBGS has also been used as a treatment of failed spinal fusion surgery (i.e., salvage therapy). Pedicle screws and interbone cages are devices used to facilitate fusion. The role of electrical stimulation of the spine for instrumented fusions, and also in patients not considered at high risk for fusion failure, is still emerging. EBGS may be considered medically necessary as an adjunct to spinal fusion surgery for patients with risk factors for failed fusion, e.g. diabetes, renal disease, smoking, alcoholism, etc.
EBGS or UBGS is also used in appendicular skeleton for the treatment of fracture non-unions. A nonunion is considered to be established when after a period of time, since injury at the fracture site shows no visibly progressive signs of healing. Complicated variables are present in fractures, e.g., degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock. Delayed union refers to a decelerating bone healing process, as identified in serial x-rays. (In contrast, nonunion serial x-rays show no evidence of healing.) When lumped together, delayed union and nonunion are sometimes referred to as “un-united fractures.”
In the appendicular skeleton, EBGS or UBGS has been used primarily to treat tibial fractures. According to orthopedic anatomy, the skeleton consists of long bones, short bones, flat bones, and irregular bones. Long bones act as levers to facilitate motion, while short bones function to dissipate concussive forces. Short bones include those composing the carpus and tarsus. Flat bones, such as the scapula or pelvis provide a broad surface area for attachment of muscles. Thus the metatarsal is considered a long bone, while the scaphoid bone of the wrist is considered a short bone. Both the metatarsals and scaphoid bones are at a relatively high risk of nonunion after a fracture.
All bones are composed of a combination of cortical and trabecular (also called cancellous) bone. Cortical bone is always located on the exterior of the bone, while the trabecular bone is found in the interior. Each bone, depending on its physiologic function, has a different proportion of cancellous to trabecular bone. However, at a cellular level, both bone types are composed of lamellar bone and cannot be distinguished microscopically.
Devices to provide EBGS may be noninvasive, with electrodes placed on the skin surface over the area of the bone to be treated. These external EBGS systems are similar to transcutaneous electrical nerve stimulators (TENS). Electrodes on the skin surface are connected to a manually adjusted stimulation controller, typically powered by batteries, which is worn by the patient on a harness or belt. In some cases it is more advantageous to implant all or part of the EBGS device. In implantable systems, the electrodes, constructed on lead wires, are placed directly on the bone, in the area of the bone, or within bone graft material. These leads are then externalized to the skin surface and connected to an external stimulation controller or more typically are arranged in a subcutaneous location where an implantable stimulation controller is subcutaneously implanted and connected to the leads. The invention described in this patent application pertains to EBGS devices in which at least one portion providing direct electrical stimulation to the bone, in the area of the bone, or within bone graft material is either permanently or temporarily implanted. The other portion, the stimulation controller, may or may not be implanted. Devices to provide UBGS are noninvasive systems: the ultrasound transmitter is placed on the skin, coupled to the body using gel, and held over the targeted bone region for the prescribed duration with a prescribed low-intensity ultrasound applied for the treatment duration.
In current practice, implanted electrical energy sources and electrode/lead wire systems are typically used to directly stimulate bone at the site of repair. Such implanted electrode/lead wires exhibit significant problems, such as infection, lead failure, and electrode/lead dislodgement. In certain applications, e.g., EBGS for treatment of bone fusions, leads are implanted at the time of bone repair surgery and left unconnected, awaiting determination of whether the bone will fuse without the aid of electrical stimulation. If the leads were externalized, then the entry/exit site in the skin must be carefully managed to avoid infection. In case of non-fusion, the leads are then connected to a stimulation controller/pulse generator. If the stimulation controller is implanted, this involves yet another procedure.
The methods and apparatus of the current invention utilize vibrational energy, particularly at ultrasonic frequencies, to overcome many of the limitations of currently known solutions for EBGS, by achieving a bone stimulation capability without the use of leads connected to a stimulation controller/pulse generator. The invention described in this patent application pertains also to UBGS devices and devices combining both UBGS and EBGS function wherein the ultrasound stimulation generator or the combined ultrasound generator and electrical stimulation controller may or may not be implanted.
The following patents, all of which are incorporated in this disclosure in their entirety, describe various aspects of using electrical stimulation for achieving various beneficial effects. U.S. Pat. No. 4,026,304 titled “Bone Generating Method and Device” by Levy describes a stimulation protocol that uses a train of pulses rather than constant direct current or voltage, using conventional lead/electrode systems. U.S. Pat. No. 5,441,527 titled “Implantable Bone Growth Stimulator and Method of Operation” by Erickson et al. describes an implantable bone growth stimulation system with electrodes implanted in the region of bone and connected via leads to an implantable stimulator/controller. U.S. Pat. No. 4,690,144 titled “Wireless Transcutaneous Electrical Tissue Stimulator” by Rise et al. describes a transcutaneous system with electrodes attached to the skin and an external controller providing for electrical field stimulation to body tissue. U.S. Pat. No. 5,405,367 titled “Structure and Method of Manufacture of an Implantable Microstimulator” by Schulman et al. describes an implantable microstimulator used generally for stimulation of tissue. U.S. Pat. No. 6,037,704 titled “Ultrasonic Power Communication System” by Welle describes the use of ultrasound energy transfer from a transmitter to a receiver for purposes of powering a sensor or actuator without being connected by a lead/wire. U.S. Pat. No. 6,366,816 titled “Electronic Stimulation Equipment with Wireless Satellite Units” by Marchesi describes a tissue stimulation system based on a wireless radio transmission requiring the charging of a battery at the receiver and separate command signals used to control the delivery of stimulation. German patent application DE4330680A1 titled “Device for Electrical Stimulation of Cells within a Living Human or Animal” by Zwicker describes a general approach to power transfer using acoustic energy for tissue stimulation.
Additionally, the following patents describe various methods and systems for the application of ultrasonic energy for achieving beneficial effects related to bone growth or the healing of fractures using ultrasound alone: U.S. Pat. Nos. 6,231,528 and 6,652,473 both titled “Ultrasonic and Growth Factor Bone Therapy: Apparatus and Method” by Kaufman et al., U.S. Pat. Nos. 6,322,527 and 5,556,372 titled “Apparatus for Ultrasonic Bone Treatment” by Talish, U.S. Pat. Nos. 5,752,924 and 5,547,459 titled “Ultrasonic Bone Therapy Apparatus and Method” by Kaufman et al., U.S. Pat. No. 5,496,256 titled “Ultrasonic Bone Healing Device for Dental Application” by Bock et al., U.S. Pat. No. 5,309,898 titled “Ultrasonic Bone Therapy and Assessment Apparatus and Method” by Kaufman et al., and U.S. Pat. No. 4,530,360 titled “Method for Healing Bone Fractures with Ultrasound”. A publication by J D Heckman, J P Ryaby, J McCabe, J J Frey and R F Kilcoyne, “Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound” The Journal of Bone and Joint Surgery, Vol. 76, Issue 1 26-34, 1994, describes the use of a UBGS system.